Polyisoprene Extra Large Condom— 510(k) K232470

Substantially Equivalent

Suretex Limited

FDA 510(k) clearance K232470 for Polyisoprene Extra Large Condom, Substantially Equivalent on 2024-05-09. Applicant: Suretex Limited.

Clearance details

Applicant: Suretex Limited
Product code: Code MOL
Advisory panel: Obstetrics/Gynecology
Date received: 2023-08-16
Decision date: 2024-05-09
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Suratthani, TH

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